Verification of HPLC for the quantitative determination method of nifedipine in tablets
DOI:
https://doi.org/10.24959/nphj.15.2000Keywords:
nifedipine, verification, HPLCAbstract
Currently a great number of generic drugs have been registered in Ukraine. The advantage of generic drugs is a relatively low cost compared to innovative medicines since creation and registration of gene-rics require less research and, consequently, less material costs for development, research and market penetration of a new drug. Because of creation of the second edition of SPhU and inclusion of articles on the finished products, we have set ourselves the goal to analyze the validation characteristics of the quantitative chromatographic determination of nifedipine in tablets and to verify the analytical procedure. Linearity of the method was determined in the range of 80-120% of the nominal concentration. Linearity of the method has been confirmed within the whole range of concentrations studied (b = 1.0031, Sb = 0.0007816, a = -0.11, Sa= 0.07891, S0 = 0.03055, r = 1.0000). It has been proven that the method suggested is characterized by sufficient convergence and accuracy over the entire range of concentrations (ΔZ = 0.06, δ% = 0.2). The intermediate precision has been confirmed by the fact that the value of the relative confidence interval for five parallel measurements of one batch of the drug meets the acceptance criterion (ΔZ = 0.22%≤1.6%). Thus, according to the results of determining the validation characteristics of the methods for quantitative determination it has been substantiated and experimentally proven that this analytical procedure can be correctly reproduced, gives accurate results and is suitable for the analysis of nifedipine tablets. In the process of verification of the method for quantitative determination of nifedipine in tablets such validation characteristics of the chromatographic method as accuracy, linearity, precision, specificity and intermediate precision have been studied. The validation characteristics of the method do not exceed the critical value of error (1.6%) and are characterized by qualitative analytical indicators. This method can be correctly reproduced in the laboratory conditions.References
Бугрова Е.А., Титова А.В., Арзамасцев А.П. // ХФЖ. – 2000. – №4. – С. 55-56.
Гризодуб А.И. // Фармаком. – 2006. – № 1/2. – С. 34 – 44.
Державна фармакопея України. – Х.: РІРЕГ, 2001. – 556 с.
Державна фармакопея України. – Доп. 1. – Х.: РІРЕГ, 2004. – 520 с.
Компендиум 2009 – лекарственные препараты. В 2-х т. / Под ред. В.Н.Коваленко, А.П.Викторова. – К.: МОРИОН, 2009. – 2224 с.
Тимошик Ю.В., Петренко В.В. // Фарм. журн. – 2009. – №3. – С. 64-69.
Шаповалов В.А. // ЖАХ. – 2002. – №2. – С. 185-186.
British Pharmacopoeia. – London: The Stationаry Office, 2009. – Vol. 1, 2. – 6481 p.
Ćwiczenia z chemii lekow / Pod red. M. Gorczycowej, F. Zejca. – Кrakov: Collegium Medium UJ, 1996. – 200 p.
He Shuhua, Lu Yi, He Deyong et al. // Chin. J. Anal. Chem. – 2004. – №4. – Р. 474-476.
Hemmateenejad B., Miri R., Kamali R. // J. Iran. Chem. Soc. – 2009. – №1. – Р. 113-120.
Niopas I., Daftsios A. C. // J. Pharm. and Biomed. Anal. – 2003. – №6. – Р. 1213-1218.
Nuran O., Ceren Y., Suslu I. // J. Pharm. and Biomed. Anal. – 2002. – №3. – Р. 573-582.
Madhusudana R. T., Jayarama R. S. // Anal. Lett. – 2004. – №10. – Р. 2079-2098.
USP37-NF32 // [Електронний ресурс]: – Режим доступу: http://www.usp.org/usp-nf/pharmacopeial-forum.
Vertzoni M.V., Reppas C., Archontaki H.A. // Anal. Chim. Acta. – 2006. – №573. – Р. 298-304.
Yang Bingyi, Mo Jinyuan, Lai Rong et al. // Chin. J. Anal. Chem. – 2004. – №10. – Р. 1304-1308.
Downloads
Published
Issue
Section
License
Copyright (c) 2015 National University of Pharmacy

This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).